MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. MEGASOFT UNIVERSAL DUAL PLUS

Catalog Number 0848

Device Problem Arcing of Electrodes (2289)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/09/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.No serial number was provided therefore a device history could not be done.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: what generator is being used? what mode on the generator is being used? what were the power settings? what handpiece/pencil and electrodes was being used? was the new return electrode another mega soft or did they switch to disposable return electrode? this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that during an unknown procedure when they used the megasoft blanket, sparks flew at the tip of the electrocautery.The electrocautery's have changed and it has continued to give problems.They have changed the megasoft, and it has worked correctly.There was a surgical delay but the procedure was successfully completed.There were no patient consequences.

Manufacturer Narrative

(b)(4), date sent: 3/16/2023.Investigation summary: the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that the 0848 pad, was returned with a cut in the seal area that did not pierce the gel area.A functional test was performed on the pad, with a multimeter, and it passed the continuity test as intended.There were no issues with the returned pad that could have contributed to the reported issue.It is possible that the damage noted on the returned sample could be possibly caused by exposing the pad to other equipment or may be a result of improper handling.As part of ethicon endo surgery quality process all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device sn: (b)(6) and no non-conformances were identified.

• Brand Name: MEGASOFT UNIVERSAL DUAL PLUS
• Type of Device: MEGASOFT UNIVERSAL DUAL PLUS
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 4545 creek road; cincinnati OH 45242
• Manufacturer (Section G): MEGADYNE MEDICAL PRODUCTS, INC.
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 16213877
• MDR Text Key: 308493024
• Report Number: 1721194-2023-00017
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K133726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0848
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2022
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1